chemQbiosciences:Manual Liquid Based Cytology

University of North Carolina (UNC)

Status: Completed

Conditions: Cervical Dysplasia; Cervical Cancer

Treatments: Procedure: Pap smear

Study type: Observational

Funder types: Other

Identifiers

NCT01837303

13-1341

Details and patient eligibility

About

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.

Full description

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Enrollment: 76 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female ages 18 years or older
• English speaking
• Presenting for pap smear examination

Exclusion criteria

• Pregnancy

Trial design

76 participants in 1 patient group

Liquid based cytology

Description:

All participants will undergo both manual and conventional automated liquid based cytology (pap smear, cervical cytology).

Treatment:

Procedure: Pap smear